Fluid-product dispensing device

ABSTRACT

An inhaler comprising: a body; at least one cover element that is movable between a closed position and an open position; individual reservoirs formed on a reservoir substrate; movable support means that receive said reservoir substrate and that are displaceable between a non-dispensing position and a dispensing position; and an indicator device for indicating doses that have been dispensed or that remain to be dispensed, said indicator device comprising: a rotary indicator element that supports indicator means, such as numbers, colors, and/or symbols; and an actuator that co-operates with said movable support means so as to cause said rotary indicator element to turn when said movable support means return from the dispensing position to the non-dispensing position.

The present invention relates to a fluid dispenser device, and moreparticularly to a dry-powder inhaler.

Dry-powder inhalers are well known in the prior art. Various typesexist. A first type of inhaler contains a reservoir receiving many dosesof powder, the inhaler being provided with metering means making itpossible, on each actuation, to remove one dose of said powder from thereservoir, so as to bring said dose into an expulsion duct in order tobe dispensed to the user. Another type of inhaler consists in packagingthe doses of powder in individual predosed reservoirs, then in openingone of the reservoirs each time the inhaler is actuated. Thatimplementation seals the powder more effectively since each dose isopened only when it is about to be expelled. In order to make suchindividual reservoirs, various techniques have already been proposed,such as an elongate blister strip or blisters disposed on a rotarycircular disk. Inhalers including individual reservoirs, such ascapsules, that are loaded into the inhaler just before said reservoir isused are also described in the prior art. The advantage of such devicesis that it is not necessary to store all of the doses inside theappliance, such that said appliance can be compact. Obviously however,the inhaler is more difficult to use, since the user is obliged to loada capsule into the inhaler before each use. All existing types ofinhalers, including those described above, present both advantages anddrawbacks associated with their structures and with their types ofoperation. Thus, with certain inhalers, there is the problem of accuracyand of reproducibility for the dose on each actuation. In addition, theeffectiveness of the dispensing, i.e. the fraction of the dose thateffectively penetrates into the user's lungs in order to have abeneficial therapeutic effect, is also a problem that exists with acertain number of inhalers. A solution for solving that specific problemhas been to synchronize the expulsion of the dose with the inhalation ofthe patient. Once again, that can create drawbacks, in particular inthat type of device, the dose is generally loaded into an expulsion ductbefore inhalation, then expulsion is synchronized with inhalation. Thatmeans that if the user drops, shakes, or manipulates the inhaler in anundesirable or inappropriate manner between the moment when the userloads the dose (either from a multidose reservoir or from an individualreservoir) and the moment when the user inhales, then the user riskslosing all or part of the dose, with said dose possibly being spreadabout inside the appliance. In that event, there can exist a high riskof overdosing the next time the device is used. The user who realizesthat the dose is not complete will load a new dose into the appliance,and while the new dose is being inhaled, a fraction of the previous dosethat was lost in the appliance could thus be expelled at the same timeas the new dose, thereby causing an overdose. In the treatmentsenvisaged, such overdosing can be very harmful, and the authorities inall countries are issuing ever-stricter requirements to limit the riskof overdosing as much as possible. With regard to opening the individualreservoirs, it has been proposed to peel off or to unstick the closurelayer. That presents the drawback of difficulty in controlling theforces to be applied in order to guarantee complete opening, withoutrunning the risk of opening the next reservoir, particularly if theopening means need to be actuated by inhalation. In a variant, it hasbeen proposed to perforate the closure layer or wall. That presents thedrawback that the cut wall-portions risk retaining a fraction of thedose inside the reservoir, so that metering accuracy and reproducibilityare therefore not guaranteed.

An object of the present invention is to provide a fluid dispenserdevice, in particular a dry-powder inhaler, that does not have theabove-mentioned drawbacks.

In particular, an object of the present invention is to provide a devicethat is simple and inexpensive to manufacture and to assemble, that isreliable in use, guaranteeing metering accuracy and meteringreproducibility on each actuation, providing an optimum yield withregard to the effectiveness of the treatment, by making it possible todispense a substantial fraction of the dose to the zones to be treated,in particular the lungs, avoiding, in safe and effective manner, anyrisk of overdosing, and that is as compact as possible, whileguaranteeing sealing and absolute integrity of all of the doses up totheir expulsion.

Another object of the present invention is to provide a device thatavoids any risk of under-dosing, with the reservoir being opened, thedose being expelled, and the emitted dose being counted only after theuser has inhaled. In addition, an object of the present invention is toavoid any risk of doses being lost in the absence of any inhalation,even if the user manipulates the device.

Another object of the present invention is to provide a device thatmakes it possible to count the number of doses that have been emitted orthat remain to be emitted.

The present invention thus provides a fluid dispenser device comprising:a body provided with a dispenser orifice; at least one cover elementthat is movable between a closed position and an open position; aplurality of individual reservoirs each containing a dose of fluid, suchas a pharmaceutical powder, said reservoirs being formed on a reservoirsubstrate; movable support means that receive said reservoir substrate,and that are displaceable between a non-dispensing position and adispensing position; and an indicator device for indicating doses thathave been dispensed or that remain to be dispensed, said indicatordevice comprising: a rotary indicator element that supports indicatormeans, such as numbers, colors, and/or symbols; and an actuator thatco-operates with said movable support means so as to cause said rotaryindicator element to turn when said movable support means return fromthe dispensing position to the non-dispensing position.

Advantageously, said rotary indicator element includes at least oneperipheral set of teeth that co-operates with the actuator.

Advantageously, said indicator device includes anti-return means thatprevent said rotary indicator element from turning in the directionopposite to that imparted by the actuator.

Advantageously, said anti-return means include a flexible finger thatco-operates with a set of teeth of the rotary indicator element.

Advantageously, said actuator is a ring provided with a first peripheralset of teeth that co-operates with the actuator.

Advantageously, said ring includes a second peripheral set of teeth thatco-operates with anti-return means that prevent said ring from turningin the direction opposite to that imparted by the actuator.

Advantageously, the first set of teeth is an inner set of teeth, and thesecond set of teeth is an outer set of teeth.

Advantageously, said actuator is pivotally mounted on the body andfirstly includes pivot means that co-operate with complementary meansprovided on said movable support means, and secondly includes drivemeans that co-operate with the rotary indicator element.

Advantageously, said indicator element is a rotary ring provided with:an inner set of teeth that co-operates with a drive finger of theactuator; and an outer set of teeth that co-operates with an anti-returnfinger.

Advantageously, while said movable support means are being displacedfrom the non-dispensing position to the dispensing position, said drivefinger passes into the following tooth of the inner set of teeth, duringwhich said anti-return finger prevents said ring from turning.

Advantageously, while said movable support means are being displacedfrom the dispensing position to the non-dispensing position, said drivefinger causes said rotary ring to turn, during which said anti-returnfinger passes into the following tooth of the outer set of teeth.

Advantageously, the angle of rotation of the rotary ring on eachactuation corresponds to one tooth of the inner set of teeth.

Advantageously, said indicator device includes blocking means thatprevent said rotary indicator element from turning at all afterindicating the last dose.

Advantageously, said blocking means comprise a different tooth in theset of teeth that co-operates with the actuator.

Advantageously, the displacement of said movable support means from thenon-dispensing position to the dispensing position is controlled by theuser inhaling.

These characteristics and advantages and others of the present inventionappear more clearly from the following detailed description of severalembodiments and variants thereof, given by way of non-limiting example,and with reference to the accompanying drawings, in which:

FIG. 1 is an external diagrammatic view of a device constituting anadvantageous variant of the invention;

FIG. 2 is a diagrammatic section view of a device constituting anembodiment of the invention, shown in the closed position;

FIG. 3 is a view similar to the view in FIG. 2, shown during opening;

FIG. 4 is a view similar to the view in FIG. 3, shown in the openposition;

FIG. 5 is a view similar to the view in FIG. 4, shown after inhalation;

FIG. 6 is a view similar to the view in FIG. 5, shown at the start ofclosure, after inhalation;

FIG. 7 is a view similar to the view in FIG. 6, shown during closure,after inhalation;

FIG. 8 is a view similar to the view in FIG. 7, shown once closed, afterinhalation;

FIG. 9 is a view similar to the view in FIG. 4, shown at the start ofclosure, in the absence of any inhalation;

FIG. 10 is a diagrammatic section view of a device constituting anotherembodiment of the invention, shown in the closed position;

FIG. 11 is a view similar to the view in FIG. 10, shown in the openposition;

FIG. 12 is a view similar to the view in FIG. 11, shown afterinhalation;

FIG. 13 is a view similar to the view in FIG. 12, shown during closure,after inhalation;

FIG. 14 is a view similar to the view in FIG. 13, shown once closed,after inhalation;

FIG. 15 is a diagrammatic view of a device constituting a variantembodiment of the invention, showing in transparency the metered doseinhaler in the closed position;

FIG. 16 is a diagrammatic section view of the FIG. 15 device;

FIG. 17 is view of a detail in FIG. 16;

FIG. 18 is a view similar to the view in FIG. 15, shown in the openposition;

FIG. 19 is a view similar to the view in FIG. 18, shown afterinhalation;

FIG. 20 is a view similar to the view in FIG. 19, shown once closed,after inhalation;

FIG. 21 is a diagrammatic section view of a device constituting anotherembodiment of the invention, shown in the closed position;

FIG. 22 is a view similar to the view in FIG. 21, shown during opening;

FIG. 23 is a view similar to the view in FIG. 22, shown in the openposition;

FIG. 24 is a view similar to the view in FIG. 23, shown afterinhalation;

FIG. 25 is a view similar to the view in FIG. 24, shown during closing,after inhalation;

FIG. 26 is a view similar to the view in FIG. 25, shown once closed,after inhalation;

FIGS. 27 a and 27 b are diagrammatic section views, respectively fromthe front and from the rear, of another embodiment of the invention,shown in the closed position;

FIGS. 28 a and 28 b are views similar to the views in FIGS. 27 a and 27b, shown in the open position;

FIGS. 29 a and 29 b are views similar to the views in FIGS. 28 a and 28b, shown after inhalation;

FIGS. 30 a and 30 b are views similar to the views in FIGS. 29 a and 29b, shown during closure, after inhalation;

FIGS. 31 a and 31 b are views similar to the views in FIGS. 30 a and 30b, shown once closed, after inhalation; and

FIG. 32 is a view similar to the view in FIG. 5, diagrammaticallyshowing the reservoir substrate and the opening means constituting anadvantageous variant of the invention.

FIG. 1 shows an external view of an embodiment of a dry-powder inhaler.The inhaler comprises a central body 10 on which there are slidablymounted two lateral elements or wings 11, 12 that form a cover when thedevice is closed and that are adapted to be moved apart in order to openthe device and thus stress the device as described below. The body 10can be approximately rounded in shape at its bottom portion, andrelatively flat at its top portion, as shown in the FIG. 1, but it couldbe of any other appropriate shape. The body 10 includes a dispenser andinhaler orifice 15 through which the user inhales while the device isbeing actuated. The two cover-forming lateral portions 11, 12 can beopened by pivoting about a common pivot axis as shown in FIG. 1, but anyother opening means can be envisaged for opening the device.Alternatively, it is possible to provide only one cover element that ismovable relative to the body, instead of the two shown in FIG. 1.

The body advantageously includes a window 19 through which the count ofthe doses that have been dispensed or that remain to be dispensed can bedisplayed in visible manner for the user. The window 19 canadvantageously be provided on or close to the pivot axis of thecover-forming cover elements 11, 12. A substrate 20 of individualreservoirs 21 can be provided inside the body. The reservoirs areadvantageously of the blister type, and the reservoir substrate ispreferably an elongate strip on which the blisters are disposed onebehind another, in known manner. The strip and the blisters are shown inpart in FIG. 32 only so as not to overload the other drawings for thepurpose of clarity. The blister strip may advantageously be constitutedby a base layer or wall that forms cavities receiving the doses ofpowder, and by a closure layer or wall that covers each of said blistersin sealed manner. The blister strip can be rolled-up inside the body,and drive means 30 for driving the strip are provided for progressivelyunrolling the blister strip and for bringing a respective blister orindividual reservoir into a dispensing position each time the device isactuated. When an individual reservoir has been emptied by inhalation,the strip portion that includes said empty reservoirs is advantageouslyadapted to be rolled-up at another location of said body 10.

Reservoir-opening means 80 are provided in, or secured to, the body 10,the opening means comprising perforator and/or cutter means forperforating or cutting the closure layer of the blisters. The openingmeans are also shown diagrammatically in FIG. 32 only so as not tooverload the other drawings for the purpose of clarity.

Movable support means 50 are adapted to support at least the reservoirthat is to be opened during the next inhalation. The movable supportmeans 50 are adapted to displace the reservoir to be emptied againstsaid opening means of the device during actuation. Advantageously, themovable support means 50 are urged by an elastically-deformable loadingelement, such as a spring, a rod, or any other equivalent resilientelement, said loading element being suitable for being prestressed inparticular while the device is being opened. Advantageously, the movablesupport means 50 are displaceable between a first position (anon-dispensing position) and a second position (a dispensing position)that is the position for opening the reservoir.

The movable support means 50 advantageously comprise a substantiallyrigid part, such as a rod, that is hinged relative to said body 10. Aguide wheel 30 that is fastened in rotary manner on said movable supportmeans 50 receives and guides the blisters. Turning the guide wheel 30thus causes the blister strip to advance in a first direction. In aparticular angular position, a given reservoir or blister is always inposition to be opened by the opening means. Advantageously, rotarypositioning means 300 for positioning said guide wheel 30 in turning canbe provided for accurately determining the angular position of saidguide wheel 30 after each turn. In an advantageous variant, thepositioning means 300 can comprise a projection or finger 301 having anend that co-operates resiliently with notches 38 that are providedaround said guide wheel 30. Advantageously, the notches 38 have anapproximately V-shaped profile that automatically guides said finger 301towards the central position of the notch, thereby guaranteeing accurateangular positioning at each turn. The positioning means 300 are visiblein FIGS. 2 and 6 in particular. The guide wheel 30 preferably forms theonly drive means for driving the reservoir substrate. One (or more)additional wheel(s) could optionally be provided so as to help guideand/or drive the reservoir substrate.

Advantageously, abutment means 350 are provided for accuratelydetermining the dispensing position of the guide wheel 30 during eachinhalation. The abutment means can comprise a lug 350 that is adapted toco-operate, when in the dispensing position, with one or morecorresponding plane surfaces of the guide wheel 30. Preferably, oneplane surface is associated with each recess. In this embodiment, theabutment 350 contributes to correct rotary positioning of the guidewheel 30 when the opening means, in particular the perforator and/orcutter means penetrate into the reservoir to be emptied. The abutment350 therefore defines not only the depth to which said perforator and/orcutter means penetrate into the reservoir, but also their centeringrelative to the reservoir, so as to guarantee optimum expulsion of thepowder and reproducibility of the dose taken on each actuation. Theabutment means 350 can be associated with the above-mentioned rotarypositioning means 300, in such a manner as to predetermine in accuratemanner each position of the guide wheel, in the non-dispensing position,in the dispensing position, and also while the guide wheel 30 is beingdisplaced between said positions. This makes it possible to avoid anyrisk of the device blocking in the event of said guide wheel being badlypositioned. The abutment means 350 are shown in FIG. 5 in particular.

While the reservoir is being displaced towards its opening position inorder to be opened by the opening means 80, the opening means arepreferably stationary relative to the body 10. However, it is possibleto envisage that the opening means could also move during the step ofopening the reservoir. For example, the opening means could be displacedtowards the reservoir while the reservoir is being displaced towards theopening means. In another variant, it is also possible to envisage thatthe reservoir and the opening means are displaced in the same directionduring actuation, the reservoir being displaced more quickly in saiddirection, such that it comes into contact with said opening means inorder to be opened.

As explained above, it is desirable for the opening means to be actuatedby the user inhaling. In order to trigger the reservoir-opening means byinhalation, an inhalation trigger system is provided that advantageouslycomprises means 60 that are displaceable and/or deformable under theeffect of inhalation, the means 60 being adapted to release the blockingmeans 100. The means 60 advantageously comprises a deformableair-chamber 61 that co-operates with the blocking means 100 of saidmovable support means 50. Inhalation by the user causes said deformableair-chamber 61 to deform, thereby making it possible to release saidblocking means 100 and therefore unblock the movable support means 50,so as to make it possible to displace the guide wheel 30, and thus thereservoir to be emptied, towards its opening position. Advantageously,the air chamber 61 can comprise a deformable membrane 62, that can beconnected firstly to the inhaler orifice 15, and secondly to saidblocking means 100 in direct or indirect manner. Thus, duringinhalation, the membrane 62 deforms and/or contracts, thereby causingsaid blocking means 100 to be displaced into an unblocking position.Advantageously, a pouch or diaphragm 62 can form the air chamber 61. Thepouch 62 is connected to the inhaler orifice 15 via a channel 151 thatis advantageously disposed around an expulsion channel 152 that isconnected to a dispenser chamber 70. The pouch 62 may be fastened to arod 101 that is connected to the blocking means 100, inhalation causingthe pouch 62 to deform thereby causing the rod 101 to pivot in order todisplace said blocking means 100. The pouch 62 may advantageously bemade of silicone, and may include a hem 620 that is adapted to form aseal with the body 10. To do this, the hem 620 can be extended by aflange 625, also made of silicone, that becomes compressed by asnap-fastener portion of the body 10 in order to achieve sealing, and inparticular to avoid any head loss in the inhalation flow. In a variant,the deformable air chamber could be made in some other way, inparticular by any deformable membrane.

The inhaler further includes a dispenser chamber 70 for receiving thedose of powder after a respective reservoir has been opened. Thedispenser chamber 70 is advantageously provided with at least onesubstantially spherical element 75, such as a bead, that is displacedinside said chamber 70 during inhalation so as to improve dispensing ofthe air and powder mixture after a reservoir has been opened, in orderto increase the effectiveness of the device.

In a particular variant, the deformable air-chamber 61 co-operates withthe dispenser chamber 70. The dispenser chamber 70 can therefore beconnected to the opening means of the reservoir, and in particular tothe perforator and/or cutter means, and can include a dispenser orifice79, advantageously connected directly to the dispenser and inhalerorifice 15 of the device. The membrane 62 can thus be connected firstlyto the inhaler orifice 15, and secondly to the dispenser chamber 70, inthe user's inhalation flow path. It can be advantageous for the openingmeans, in particular for the perforator and/or cutter means, to beformed directly on said dispenser chamber 70, e.g. at the end of achannel 69 leading to said chamber 70.

After inhalation, when the user closes the device, all of the componentsreturn to their initial, rest position, i.e. the movable support means50 pivot about their pivot axis to return to their non-dispensingposition by moving away from the reservoir-opening means, and the loadelement is also returned to its initial rest position in which it is notcompressed or deformed. The device is thus ready for a new utilizationcycle.

In a variant, other inhalation trigger means could also be used, e.g.using a pivotable valve flap that, while the user is inhaling, pivotsunder the effect of the suction created by the inhalation, with pivotingof the valve flap causing the blocking means blocking the movablesupport means to be released, thereby causing the reservoir to bedisplaced towards the opening means.

The movable support means 50 that support the guide wheel 30 mayadvantageously include an extension 501, indicated in FIGS. 2 and 5,that serves in particular to co-operate with the blocking means 100.Furthermore, the extension may also serve to substantially block a hole1550 provided in the device, when the movable support means are in thedispensing position. In the non-dispensing position, the inhalation flowthus passes in part via the hole 1550. After the movable support means50 are displaced into the dispensing position, thereby causing the hole1550 to be blocked substantially and the reservoir to open, theinhalation flow is channeled mainly towards said open reservoir. Thisimproves effectiveness during inhalation and helps to ensure that thereservoir is emptied in optimum manner.

In another advantageous aspect of the inhaler, the individual reservoirsor blisters 21 are formed on an elongate strip 20 that is stored in theform of a roll inside the body 10 of the device. Advantageously, therolled-up blister strip is held by inner walls of said body 10 withoutits “rear” end (rear in the displacement direction of the blister strip)being fastened relative to said body 10, thereby enabling the blisterstrip to be assembled more easily inside the device. The blister stripis advantageously displaced by means of the guide wheel 30 thatadvantageously presents at least one and preferably more recesses 31,shown in FIG. 6, having a shape that corresponds substantially to theshape of the blisters. Thus, when the guide wheel 30 turns, it drivesthe blister strip in the first direction. Naturally, in a variant or inadditional manner, it is possible to use other means for advancing theblister strip, e.g. providing a profile on the longitudinal lateraledges of the blister strip, said profile being adapted to co-operatewith appropriate drive means. In addition, holes formed along thelateral edges of the blister strip could also be used to cause theblister strip to advance by means of toothed wheels co-operating withsaid holes, as with photographic film.

In still another aspect of the inhaler, a dose counter or indicatordevice is also provided. The device may include numbers or symbols thatare marked directly on the blister strip, and that are visible throughan appropriate window in the body of the device. In a variant, it ispossible to envisage using one or more rotary disks including numbers orsymbols, as described below.

FIGS. 2 to 9 show an advantageous embodiment of the present invention.With reference to this embodiment, the device includes a body 10 onwhich two cover elements 11, 12 are advantageously hinged about a commonhinge axis, as shown in FIG. 1. For the purpose of clarity, only one ofthe cover elements, specifically the cover element shown on therighthand side of the device and indicated by numerical reference 12, isshown in the figures. The displacements of the various parts areindicated diagrammatically by arrows in certain figures.

Said movable cover element 12 is connected to a cocking member 800,advantageously via an opening 109 that may be oblong in shape and inwhich there is received a lug 801, or the like, of said cocking member800. Advantageously, the cocking member 800 is pivotally mounted on thebody 10 about a pivot axis. The cocking member 800 supports the loadingelement 51 that, in this embodiment, is made in the form of a helicalspring. The spring 51 co-operates with a rod 810, connected at one endto said helical spring 51 and at its other end to a cam surface 910provided on said movable support means 50, said rod being describedbelow. While the cocking member 800 is being displaced about its pivotaxis during displacement of the movable cover element 12, the rod 810 isthus adapted to compress the spring 51 when the cover element 12 isopen, and to decompress said spring 51 when said cover element 12 isclosed. In its portion in contact with the cam surface 910, the rod 810advantageously includes a rounded portion 811, such as a ball-shapedend, to encourage the rod 810 to slide over said cam surface 910. Thecocking member 800 further includes a projection 820 that is adapted toco-operate with an extension portion 520 of the movable support means50, as described in more detail below. The cocking member 800 furtherincludes guide means 850, advantageously formed in the form of a groovein which there is received a projection 1010 that is connected to adrive element 1000, that is also described in more detail below.Advantageously, said groove 850 comprises at least two portions ofdifferent slopes, having functions that are also described below.

In this embodiment, the movable support means 50 are made in the form ofa part that is pivotally mounted on the body about a pivot axis 511. Themovable support means 50 also incorporate an extension 501,advantageously in the shape of a fin. The above-mentioned cam surface910 is formed on said movable support means 50 so that when the spring51 is loaded while opening the movable cover element 12, said movablesupport means 50 are urged towards their dispensing position by said rod810 being thrust by the compressed spring 51. Blocking means 100 areprovided for retaining said movable support means 50 in saidnon-dispensing position, shown in particular in FIG. 2. Said blockingmeans 100 advantageously include a blocking element 110 that is adaptedto co-operate with said extension 501 of said movable support means 50.Said blocking means 100 are advantageously connected by means of a rod101 to the deformable diaphragm 62 that is sensitive to inhalation bythe user, so that while the user inhales, said diaphragm deforms, thuscausing the rod 101 to pivot, and consequently said blocking element110, thereby releasing the extension 501. This enables said movablesupport means 50 to be displaced towards their dispensing position underthe effect of the force exerted by the compressed spring 51. Thedisplacement of the movable support means 50 causes an individualreservoir to be opened, as described above.

Advantageously, the drive element 1000 is pivotally mounted inside thebody 10. As explained above, the drive element 1000 co-operates firstlywith the groove 850 of the loading member 800 by means of its projection1010. In addition, another projection 1020 of said drive element 1000co-operates with a set of teeth 37 of the guide wheel 30. When the coverelement 12 is in its closed position, the projection 1020 meshes withsaid set of teeth 37. When the cover element 12 is opened, theprojection 1010 of the drive element slides in the groove 850 of theloading member causing said drive element 1000 to pivot about its pivotaxis. Such pivoting causes the drive projection 1020 to disengage fromsaid set of teeth 37 of the guide wheel 30. This disengaged position isshown in FIG. 4. When the user inhales, the movable support means 50 aredisplaced towards the dispensing position. Since the guide wheel 30 isfastened in rotary manner on said movable support means 50, obviously itis displaced together with said movable support means towards theopening means. In the dispensing position, the drive projection 1020 ofthe drive element 1000 is thus situated facing another tooth of the setof teeth 37 of the guide wheel 30, as clearly visible in FIG. 5. Then,when the user closes the cover element 12, the projection 1010 of thedrive element once again slides in the groove 850 of the loading member800, this time in the other direction, which in turn causes said driveelement 1000 to pivot. The drive projection 1020 thus comes to mesh withanother tooth, in particular the next tooth, of the set of teeth 37 ofthe guide wheel 30, as shown in FIGS. 6 to 8. Meshing advantageouslyoccurs during the beginning, in particular in the first half, of thereturn stroke of the movable cover element 12 towards its closedposition, and continuing the return stroke causes the guide wheel 30 toturn under the effect of said drive element 1000. In this way, the guidewheel 30 turns about its axis of rotation so as to bring the next fullblister to face the opening means with a view to the next actuation ofthe device and thus the next dispensing of a dose. As explained above,the groove 850 of the loading member advantageously comprises twoportions of different slopes. Starting from the closed position of themovable cover element, the first portion of the groove 850advantageously does not cause the drive element 1000 to pivot, and it isonly in the second portion of steeper slope in the groove 850 that thedrive element 1000 is caused to pivot about its pivot axis so as tocause the drive element to disengage from the set of teeth 37.Consequently, when the user closes the cover, the drive projection 1020of the drive element 1000 returns quickly inside the next tooth of theset of teeth 37, and continuing the return stroke of the movable coverelement towards its closed position causes said guide wheel 30 to turn.

The cam surface 910 also includes at least two portions of differentslopes that are advantageously separated by a vertex 911. Starting onceagain from the closed position of the movable cover element, the firstslope portion on which the rod 810 slides, enables the spring 51 to becompressed, as describe above. When the spring is loaded, i.e.compressed, the cam surface 910 provides a second different slopeportion with which the rod 810 co-operates when the device is in itsopen position. The rod 810 preferably exerts a force that issubstantially perpendicular on the second cam surface portion, as shownin FIG. 4. In this way, the loaded position is stable.

In the open position, shown in FIG. 4, the movable support means 50 thatare urged towards the dispensing position by the compressed spring 51thus exert a force on the blocking means 100, in particular on theblocking element 110 of the blocking means, by means of the extension501. At the opposite end of the rod 101, in the proximity of theconnection of said rod 101 to the diaphragm 62, a bearing zone 103 isadvantageously provided, adapted to co-operate with a complementary zone503 provided on the movable support means 50. The bearing zone 103 makesit possible to create a loaded position that is stable between saidmovable support means 50 and said blocking means 100. Each of the twomeans are movable, and the dual contact, firstly with a force exertedupwards (with reference to the position shown in FIG. 4) by theextension 501 on the shoulder portion 110, and secondly with a forceexerted downwards by the bearing zone 103 on the complementary zone 503,guarantees balanced blocking that can be released only by the userinhaling, causing the diaphragm 62 to deform, and thus the rod 101 ofthe blocking means 100 to pivot.

After inhalation, i.e. in the dispensing position shown in FIG. 5, theblocking means 100 have pivoted, and the movable support means 50 havebeen displaced upwards by the compressed spring 51. The pivoting of theblocking means, in particular of the blocking element 110, causes an endportion 115 of the blocking element 110 to project out from the body 10,as shown in particular in FIG. 5. Then, when the user closes the movablecover element 12, said cover element 12, when fully closed, comes tobear against said end portion 115, thereby returning the blocking means100 to their initial position with the diaphragm 62 that is alsoreturned to its initial position, as shown in particular in FIG. 8.

Thus, by opening the inhaler, the user loads the system. If the userdoes not inhale and closes the inhaler, said inhaler merely returns toits start position without displacing the reservoirs 21 or the blockingmeans 100. There is thus no risk of a reservoir (and thus an active doseof substance) being lost by accidental or incomplete actuation in whichthe user does not inhale between opening and closing. Opening thereservoir, emptying it, dispensing the powder into the lungs of theuser, and displacing the blister strip to bring a new full reservoir toface the opening means is thus possible only if the user inhales.

In addition, after inhalation and thus displacement of the movablesupport means 50 towards the dispensing position, closure of the movablecover element 12 returns the loading member 800 towards its startposition. As shown in FIG. 6, it is at this moment that the projection820 of the loading member 800 co-operates with the extension portion 520of the movable support means 50 so as to push said movable support means50 and thus cause them to pivot towards their non-dispensing position.The movable support means 50 are thus advantageously returned towardsthe non-dispensing position that is mechanically linked to the closureof the movable cover element 12.

As explained above, FIGS. 2 to 9 show only one movable cover element 12,but naturally a second movable cover element, advantageously symmetricalto the movable cover element shown, could be provided around the body10, as shown in FIG. 1. Advantageously, the two movable cover elements11, 12 are then meshed together so as to guarantee symmetrical openingand closing of said two movable cover elements. They can be meshedtogether in the proximity of their pivot point.

FIGS. 21 to 26 show a variant embodiment in which the cam surface 910 isreplaced by a connecting rod or toggle 9000 that is pivotally connectedfirstly to the rod 810 that is connected to the spring 51 and secondlyto the movable support means 50, by means of two respective pivot axes9001 and 9002. In the closed position, shown in FIG. 21, the toggle 9000forms an angle relative to the rod 810 and the longitudinal axis of thespring 51. When the user opens the cover elements 11, 12, the user pullson the axis 9001, displacing the loading member 800 towards the right inthe figure, as shown by the arrows in FIG. 22. Since the movable supportmeans 50 are stationary as a result of being retained by the blockingmeans 100, the toggle thus becomes straight so as to align itself withthe axis of the rod 810 and of the spring 51, as shown in FIG. 22. Thiscauses the spring 51 to compress as a result of the toggle being longerthan it is wide. In the open position shown in FIG. 23, the toggleadvantageously extends beyond the longitudinal axis of the rod 810 andof the spring 51, so as to guarantee an open position that is stable. Asabove, if the user closes the inhaler without inhaling, nothing happensat the blister strip, which has not moved. After inhalation (FIG. 24),the blocking means are released, as described above, a reservoir isopened, and a dose is expelled. Then, when the user closes the coverelements 11, 12 (FIGS. 25 and 26), the toggle 9000 pivots back towardsits initial position, thereby returning the movable support means 50into their non-dispensing position. The blocking means 100 and theconnection means 1000 are substantially identical to those in theembodiment in FIGS. 2 to 9, but variants can also be envisaged.

FIGS. 10 to 14 show another embodiment of the invention. In thisembodiment, the identical or similar elements are represented byidentical numerical references, whereas the elements that differ arerepresented by numerical references including primes.

The embodiment differs from the above mainly by the loading means thatare made in another way. In this second embodiment, there is no longer aspring 51 but a rod 51′ that can flex so as to exert the resilient forceon the movable support means. The rod 51′ is thus firstly fastened tothe movable support means 50, and secondly it is connected to thecocking member 800, advantageously by means of a projection 51″ thatpenetrates into a groove 910′ of appropriate shape. The groove forms acam surface 910′ against which said projection 51″ of the rod 51′ comesto slide during opening and closing of the movable cover elements 11,12. The shape of the groove, approximately in the shape of a circulararc, thus comprises a first groove portion and a second groove portionthat are connected at a vertex 911′. As for the cam surface 910 of thefirst embodiment in FIGS. 2 to 9, the first portion of the groove 910′serves to load the spring, i.e. the resilient rod 51′, by deforming it,whereas the second portion of the groove 910′ makes it possible toprovide a position that is stable in the loaded position, i.e. in theopen position. When the device is loaded, as shown in FIG. 11, theflexed flexible rod 51′ thus exerts a force on the movable support means50, so as to urge them towards their dispensing position. In mannersimilar to the first embodiment in FIGS. 2 to 9, the movable supportmeans 50 are held in the non-dispensing position by the blocking means100 that can be made in manner very similar to the manner describedabove. When the user inhales, the blocking means 100 are released andthe movable support means 50 can be displaced towards their dispensingposition towards the opening means.

Another difference in this embodiment relates to the displacement meansfor displacing the reservoir substrate, in particular the blister strip.In this second embodiment, the guide wheel 30 meshes with a toothedwheel 730, itself co-operating with a drive element 1000′. Whereas inthe first embodiment in FIGS. 2 to 9, the drive element 1000 wasconnected firstly to the groove 850 of the loading member 800, andsecondly directly to the set of teeth 37 of the guide wheel 30, in thisembodiment the drive element 1000′ is connected firstly to the groove850 of the loading member 800, as in the first embodiment, but it isconnected secondly to the toothed wheel 730 interposed between the driveelement 1000′ and the guide wheel 30. For the remainder, the operationis similar to the first embodiment, i.e. when the user opens the movablecover elements 11, 12, the drive element 1000′ slides in the groove 850,advantageously at a projection 1010′. Since the first groove portion 850is substantially parallel or equidistant relative to the pivot axis ofthe movable cover elements 11, 12, the first groove portion does notsubstantially cause action on the drive element 1000′, whereas thesecond groove portion, of different slope, causes said drive element1000′ to pivot and become disengaged from the toothed wheel 730. If theuser closes the device without inhaling, the drive element 1000′ merelyslides back into the groove 850 and once again becomes meshed with thesame tooth of the toothed wheel 730, such that nothing happens to thereservoir substrate or to the blocking means 100. In contrast, afterinhalation, when the user closes the movable cover elements, the driveelement 1000′ becomes meshed in another tooth of the toothed wheel inmanner similar to the manner described above for the first embodiment.

FIGS. 27 a to 31 b show another embodiment in which the reservoirsubstrate 20 is displaced in the first direction each time the coverelements 11, 12 are opened. In this variant, if the user closes withoutinhaling, the reservoir substrate is returned to its initial position.In the absence of any inhalation, the reservoir substrate thus movesback and forth so as to return exactly to its start position afterclosure. Thus, this also guarantees that doses are not lost, even in theevent of incomplete manipulation of the device. In the event ofinhalation, closure after inhalation does not cause the reservoirsubstrate to be displaced, so that for the next actuation, it is thenext full reservoir that is brought to face the opening means duringopening of the cover elements.

In this embodiment, the loading means comprise a rod 1051′ that firstlyis fastened to the movable support means 50, and that secondly slides bymeans of a projection 1051″ in a groove 1910 that is provided in aloading member 1800, connected to said movable cover elements 11, 12.The loading operation is similar to the loading operation described withreference to FIGS. 10 to 14. The loading member 1800 is meshed with theguide wheel 30, as can be seen more clearly in the views from the rear.Connection means 1000″ are provided for co-operating with the guidewheel 30 so long as the movable support means 50 have not been displacedinto their dispensing position, after inhalation. After inhalation, theconnection means, advantageously including a projection that co-operateswith a set of teeth of the guide wheel 30, are deactivated, i.e. they nolonger co-operate with the guide wheel. When the user closes the device,the guide wheel together with the movable support means thus return tothe non-dispensing position, without turning about the axis of rotation.It is only when fully closed that the connection means once again meshwith the guide wheel.

The device of the invention can also include a dose indicator or counter120 that is adapted to count or indicate to the user the number of dosesthat have been dispensed or that remain to be dispensed. In theembodiment shown, the indicator is adapted to count 60 doses. FIGS. 15to 20 show an actuation cycle of the device and the manner in which theindicator is actuated. The indicator advantageously comprises a ring 127provided with an inner set of teeth 128 and with an outer set of teeth129 and including numbers 125, e.g. from 0 to 60, printed on one of itsfaces. The ring is mounted in such a manner that the numbers passsuccessively into the window 19 of the body 10. The inner set of teeth128 is advantageously adapted to co-operate with an actuator 160,whereas the outer set of teeth 129 is advantageously adapted toco-operate with non-return means 170 that are adapted to prevent theindicator ring 127 from turning in the opposite direction to thedirection that is imposed thereto by the actuator 160.

An object of the invention is to avoid counting doses that have not beendispensed, e.g. in the event of a manipulation error, or of anincomplete manipulation of the device. It is thus essential that thecounter or indicator is actuated only once the user has inhaled, sinceit is this inhalation that makes it possible for the blister to open andthe dose contained therein to be dispensed. For this purpose, the deviceincludes an actuator 160 that is pivotally mounted on the body 10. Theactuator 160 includes engagement means 165, in particular teeth, adaptedto mesh in a set of teeth 565, or complementary teeth provided onmovable support means 50. Thus, when the user opens the device and loadsthe loading means of the device, the movable support means 50 do notmove since they are held in the non-dispensing position by the blockingmeans 100. Thus, nothing happens to the indicator since the actuator 160that is pivotally mounted on the body 10 and meshed with the movablesupport means 50, also remains stationary. If the user closes the devicewithout inhaling, obviously still nothing happens since the movablesupport means 50 still remain stationary. In this way, it is guaranteedthat the indicator does not count doses if there is no inhalation. Fromthe loaded position, shown in FIG. 18, if the user inhales, the movablesupport means 50 are displaced into their dispensing position towardsthe opening means. This displacement thus causes the actuator 160 topivot in a first direction, as shown in FIGS. 18 and 19. The actuator160 includes a finger 168 that is meshed in the inner set of teeth 128of the indicator ring 127. In the first direction of displacement, thefinger 168 of the actuator can slide over the slope of the correspondingtooth so as to become positioned facing the next tooth. In parallel, thenon-return means 170, in particular a non-return finger 179, co-operatewith the outer set of teeth 129 of the ring 127 so as to prevent saidring from turning under the effect of friction, e.g. exerted by thefinger 168 of the actuator on the inner set of teeth 128. Afterinhalation, when the user closes the device, the movable support means50 are returned to their rest position, i.e. the non-dispensingposition. This movement thus causes the actuator 160 to pivot in thedirection opposite to the first-described direction, since therespective sets of teeth 165, 565 of the actuator and of the movablesupport means pivot in the direction opposite to the above-describeddirection. In the displacement in the opposite direction, the finger 168of the actuator 160 presses into the tooth in which it is positioned soas to cause the ring 127 to turn, as shown in FIG. 20. In parallel, thenon-return finger 179 slides over the slope of the tooth so as to becomepositioned in the following tooth. In the embodiment shown, theindicator is adapted to indicate the number of doses that remain to bedispensed, so that the number displayed decreases on each actuation.Naturally, the reverse is also possible, i.e. a counter that counts thenumber of doses that have been dispensed. Advantageously, it is possibleto provide blocking means for blocking the indicator after the last dosehas been dispensed. The blocking means can take different forms, anadvantageous form being to provide a different shaped tooth on the innerset of teeth so that the actuator can no longer become meshed in thenext tooth in order to continue causing said indicator ring to turn.Other means of preventing the ring from turning after the last dose hasbeen dispensed can also be envisaged.

In all of the embodiments described above, the blister strip is formedby a strip presenting two ends. In a variant, it is possible to use acontinuous strip. Other modifications are also possible without goingbeyond the ambit of the present invention.

The present invention therefore makes it possible to provide adry-powder inhaler that performs the following functions:

-   -   a plurality of individual doses of powder stored in individual        sealed reservoirs, e.g. 30 or 60 doses stored on a rolled-up        strip;    -   the powder is released by perforation that is achieved by the        user inhaling, the blister being perforated by means of an        inhalation detector system that is coupled to a prestressed        release system;    -   appropriately-shaped drive means that are engaged with blisters        so as to displace the blister strip on each actuation, and to        bring a new reservoir into a position in which it is to be        opened by appropriate opening means; and    -   means for avoiding doses being lost in the event of the inhaler        being opened, but in the absence of any inhalation. In this        event, when the inhaler closes, the device returns exactly to        its start position;    -   a dose indicator adapted to count the doses only in the event of        inhalation.

Other functions are also provided by the device of the invention asdescribed above. It should be observed that the various functions, evenif they are shown as being provided simultaneously on the variousembodiments of the inhaler, could be implemented separately. Inparticular, the inhalation trigger mechanism could be used regardless ofthe type of reservoir-opening means, regardless of the use of a doseindicator, regardless of the way in which the individual reservoirs arearranged relative to one another, etc. The prestressing means and theinhalation trigger system could be made in some other way. The sameapplies for other component parts of the device.

The inhaler of the invention, incorporating all or some of theabove-described functions, provides performance that is superior to theperformance of existing devices. In particular, the inhaler of theinvention preferably provides a reservoir emptying factor of at least90% on each actuation. The emptying factor, corresponding to thepercentage of fluid that is expelled from an open reservoir while thedevice is being actuated, is advantageously greater than 95%, preferablyeven greater than 97%. In particular, this high emptying factor is evengreater than the performance obtained with active inhalers that aregenerally more effective than passive inhalers, and in which it is notthe inhalation flow that empties the blister and expels the dose but aflow of compressed air that is released while inhaling. The highemptying factor guarantees that the device of the invention is aseffective as possible. Coupled with the inhalation-triggered opening,the high emptying factor guarantees that the fluid, specifically thepowder, is dispensed in optimum manner into the user's lungs. Theinvention also provides improved emptying regularity of the reservoirsduring successive actuations. Thus, for ten reservoirs of a blisterstrip, for example, it turns out that the emptying factor varies by lessthan 15%, advantageously by less than 10%, preferably by less than 5%from one reservoir to another. This improved regularity guaranteesimproved dose reproducibility, and therefore also improved effectivenessof the device of the invention.

Various modifications can also be envisaged by a person skilled in theart, without going beyond the ambit of the present invention, as definedby the accompanying claims. In particular, the various characteristicsand functions of the device described with reference to the variousembodiments and variants can be adapted to all of the embodiments andvariants, and can be combined together in any appropriate manner.

1. A fluid dispenser device, characterized in that it comprises: a bodyprovided with a dispenser orifice; at least one cover element that ismovable between a closed position and an open position; a plurality ofindividual reservoirs each containing a dose of fluid, such as apharmaceutical powder, said reservoirs being formed on a reservoirsubstrate; movable support means that receive said reservoir substrate,and that are displaceable between a non-dispensing position and adispensing position; and an indicator device for indicating doses thathave been dispensed or that remain to be dispensed, said indicatordevice comprising: a rotary indicator element that supports indicatormeans, such as numbers, colors, and/or symbols; and an actuator thatco-operates with said movable support means so as to cause said rotaryindicator element to turn when said movable support means return fromthe dispensing position to the non-dispensing position.
 2. A deviceaccording to claim 1, in which said rotary indicator element includes atleast one peripheral set of teeth that co-operates with the actuator. 3.A device according to claim 1, in which said indicator device includesanti-return means that prevent said rotary indicator element fromturning in the direction opposite to that imparted by the actuator.
 4. Adevice according to claim 3, in which said anti-return means include aflexible finger that co-operates with a set of teeth of the rotaryindicator element.
 5. A device according to claim 1, in which saidrotary indicator element is a ring provided with a first peripheral setof teeth that co-operates with the actuator.
 6. A device according toclaim 5, in which said ring includes a second peripheral set of teeththat co-operates with anti-return means that prevent said ring fromturning in the direction opposite to that imparted by the actuator.
 7. Adevice according to claim 5, in which the first set of teeth is an innerset of teeth, and the second set of teeth is an outer set of teeth.
 8. Adevice according to claim 1, in which said actuator is pivotally mountedon the body and firstly includes pivot means that co-operate withcomplementary means provided on said movable support means, and secondlyincludes drive means that co-operate with the rotary indicator element.9. A device according to claim 8, in which said indicator element is arotary ring provided with: an inner set of teeth that co-operates with adrive finger of the actuator; and an outer set of teeth that co-operateswith an anti-return finger.
 10. A device according to claim 9, in which,while said movable support means are being displaced from thenon-dispensing position to the dispensing position, said drive fingerpasses into the following tooth of the inner set of teeth, during whichsaid anti-return finger prevents said ring from turning.
 11. A deviceaccording to claim 9, in which, while said movable support means arebeing displaced from the dispensing position to the non-dispensingposition, said drive finger causes said rotary ring to turn, duringwhich said anti-return finger passes into the following tooth of theouter set of teeth.
 12. A device according to claim 11, in which theangle of rotation of the rotary ring on each actuation corresponds toone tooth of the inner set of teeth.
 13. A device according to claim 1,in which said indicator device includes blocking means that prevent saidrotary indicator element from turning at all after indicating the lastdose.
 14. A device according to claim 13, in which said blocking meanscomprise a different tooth in the set of teeth that co-operates with theactuator.
 15. A device according to claim 1, in which the displacementof said movable support means from the non-dispensing position to thedispensing position is controlled by the user inhaling.